Educational Interventions on Diabetic Foot Care

Diabetes Mellitus Clinical Trial

Official title:

Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811989
• Other study ID #: CEICVS134/2020
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients.

This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care

• Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls, after obtaining the patients' consent.

The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.

Description:

Specific Aims

1. To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time.

2. To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health.

3. To examine the mediating role of representations about diabetic foot in the relationship between knowledge about foot care and adherence to diabetic foot care, over time, controlling for health literacy.

4. To examine the moderating role of foot pain, foot function, and footwear between representations about diabetic foot and adherence to diabetic foot care/ perceived foot health, over time.

Data Analysis:

Generalized Mixed Models, which allow examining changes over time including longitudinal mediation and moderation.

Sample size calculation:

Considering a dropout rate of 10%, the sample size required is 60 patients (20 per group).

Procedure:

Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 31, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Diabetes mellitus;

• Diagnosis of Diabetic Foot;

• To benefit from the first assessment and follow-up at the Multidisciplinary Diabetic Foot Consultation of the hospitals where data collection will take place.

Exclusion Criteria:

• Presence of clinical dementia described in the patient's clinical record;

• Cognitive disability to answer the questionnaires;

• Severe visual and/or hearing impairment.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot

Intervention

Behavioral:
• Instructive video on diabetic foot care
In the video, the diabetic foot care is presented verbally and appropriately captioned, as well as exemplified by real patients and health professionals from the hospital
• Informative leaflet with real-time guided reading
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
• Informative leaflet to read at home
Patients receive a leaflet about diabetic foot care to read at home.
• Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.

Locations

Country	Name	City	State
Portugal	Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa	Penafiel	Porto
Portugal	Centro Hospitalar Universitário do Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
University of Minho	Foundation for Science and Technology, Portugal

Country where clinical trial is conducted

Portugal, 

References & Publications (8)

Bastos F, Severo M, Lopes C. [Psychometric analysis of diabetes self-care scale (translated and adapted to Portuguese)]. Acta Med Port. 2007 Jan-Feb;20(1):11-20. Epub 2007 May 23. Portuguese. — View Citation

Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. — View Citation

Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961. — View Citation

Hasnain S, Sheikh NH. Knowledge and practices regarding foot care in diabetic patients visiting diabetic clinic in Jinnah Hospital, Lahore. J Pak Med Assoc. 2009 Oct;59(10):687-90. — View Citation

Lincoln, N. B., Jeffcoate, W. J., Ince, P., Smith, M., & Radford, K. A. (2007). Validation of a new measure of protective footcare behaviour: the Nottingham Assessment of Functional Footcare (NAFF). Practical Diabetes International, 24, 207-211. doi:10.1002/pdi.1099

Paiva D, Silva S, Severo M, Ferreira P, Santos O, Lunet N, Azevedo A. Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Educ Couns. 2014 Nov;97(2):269-75. doi: 10.1016/j.pec.2014.07.024. Epub 2014 Jul 22. — View Citation

Pandis N. Randomization. Part 3: allocation concealment and randomization implementation. Am J Orthod Dentofacial Orthop. 2012 Jan;141(1):126-8. doi: 10.1016/j.ajodo.2011.09.003. — View Citation

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot pain	Foot pain will be assessed through the respective subscale of the Foot Health Status Questionnaire (Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to significant or extreme foot pain and 100 to no foot pain or discomfort.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Other	Foot function	Foot function will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to severe limitation in the performance of physical activities because of the feet and 100 to no limitation.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Other	Footwear	Footwear will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to severe problems obtaining appropriate footwear and 100 to no problems.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Other	Clinical Data	Clinical variables (e.g., HbA1c levels, presence/absence of active ulcer and duration of diabetic foot ulcer, recommendation to use therapeutic footwear) will be assessed through a Clinical Questionnaire developed for this study	Baseline (T0)
Other	Health literacy	Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).	Baseline (T0)
Other	Sociodemographic data	The sample will be characterized using a Sociodemographic Questionnaire developed for this study (e.g. age, marital status, gender, socio-economic level).	Baseline (T0)
Primary	Adherence to the diabetic foot care behaviours	Adherence to foot care behaviors will be assessed through the Nottingham Assessment of Functional Foot Care (Lincoln, Jeffcoate, Ince, Smith, & Radford, 2007). Composed of 29 items whose answers are given on a Likert scale ranging from 0 to 3. Higher scores correspond to a higher frequency of foot care behaviors.	Changes from baseline to two weeks post-test and after a three month follow-up
Primary	Adherence to the diabetic foot care behaviours	The level of foot self-care (indirect measure of adherence) will be assessed through the subscale of Foot Care of the Summary Diabetes Self-Care Activities Questionnaire (Original Version by Toobert, Hampson, & Glasgow, 2000; Portuguese Version by Bastos, Severo, & Lopes, 2007). Composed of 3 items in which patients are asked how many of the last seven days did they perform the respective foot care behaviour. Therefore, answers are given on a scale between 0 and 7, and its score is calculated through the mean number of days. Higher scores indicate higher levels of foot self-care.	Changes from baseline to two weeks post-test and after a three month follow-up
Primary	Knowledge on foot care	Knowledge on foot care will be assessed through the Questionnaire on Knowledge of Foot Care (Hasnain & Sheikh, 2009). Each correct answer is scored with 1 point and higher scores indicate better knowledge about foot care.	Changes from baseline to two weeks post-test and after a three month follow-up
Primary	General foot health	General foot health will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to the perception of poor foot health state/condition and 100 to the perception of excellent foot health.	Changes from baseline to two weeks post-test and after a three month follow-up
Secondary	Representations about diabetic foot	Representations about diabetic foot will be assessed through the Illness Perception Questionnaire - Brief (IPQ-B; Figueiras et al., 2010). The response scale ranges from 0 to 10. Higher scores indicate more threatening representations regarding diabetic foot.	Changes from baseline to two weeks post-test and after a three month follow-up